YY/T 1748-2021 Translated English of Chinese Standard (YY/T1748-2021, YYT 1748-2021): Neurovascular implants -- Intracranial embolization coils [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]https://www.chinesestandard.net, 21. aug. 2022 - 43 sider This Standard specifies general requirements, design properties and laboratory design evaluations for coils, pushers and coil systems. This Standard is applicable to coil products for the treatment of intracranial aneurysms, arteriovenous fistulas, arteriovenous malformations and other intracranial vascular diseases, as well as the pushers and introducer sheaths that are matched with them. This Standard does not apply to coil products for the treatment of other vascular aneurysms. |
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acceptance criteria accessories aneurysm Appearance inspection Appendix applicable ASTM carried Coil fails coil system compatibility Conditions Conditions Connection strength Create a test described in B.2 described in B.3 Description of results design properties detach the coil detach zone Detaching force Detaching performance Device Evaluation Strategy Dimensional verification Embolization endotoxins Environmental control temperature Galvanic corrosion GB/T hydrogel Intracranial Embolization Intraoperative product replacement introducer sheath length of coil location of failure material testing machine maximum force Medical Devices Newtons N potential failure modes Presentation of results primary coil product instructions Purpose The purpose Pushing performance Matching pushing process radio frequency heating report should include report The test requirements of B.4 requirements of YY/T Sampling Sampling secondary shape standard deviation strength of detach Strength of stretch stretch resistance wire Swelling properties test method based Test method Create test report test results test samples thrombosis Thrombus type and location Universal material testing Withdrawing performance